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Bioequivalence of Two Commercial Amoxicillin Suspensions

Information source: University of Campinas, Brazil
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bioequivalence of Amoxicillin

Intervention: amoxicillin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Campinas, Brazil

Official(s) and/or principal investigator(s):
Francisco C Groppo, PhD, Principal Investigator, Affiliation: University of Campinas, Brazil
Ana PP Cione, Chem., Study Chair, Affiliation: BIOAGRI Laboratórios Ltda


The aim of the present study was to compare the pharmacokinetic profiles and to evaluate the bioequivalence of two commercial amoxicillin-suspension formulations in healthy Brazilian volunteers.

Clinical Details

Official title: Bioequivalence Study of Two Commercial Amoxicillin Suspension Formulations in Healthy Human Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Changes in plasmatic amoxicillin concentrations along time measured by HPLC.

Detailed description: Under fasting condition, 25 volunteers (13 males and 12 females) were included in this randomized, open-label, two-period crossover (1-week washout interval) bioequivalence study. Blood samples were collected at pre-dose (0h) and 0. 5, 1, 1. 33, 1. 66, 2, 2. 5, 3, 4, 6, 8 and 12 hours after drug ingestion. Pharmacokinetic parameters (Cmax, Tmax, T1/2, Area-under-curve0-12h and Area-under-curve0-inf) were calculated from plasma concentrations for both formulations in each subject.


Minimum age: 19 Years. Maximum age: 46 Years. Gender(s): Both.


Inclusion Criteria:

- negative to HIV, hepatitis B virus, hepatitis C virus, addictive drugs and pregnancy

test for women

- age between 19 and 46 years

- weight between 52 and 85 kg and body mass index between 17. 6 and 28. 4kg/m2

- ability to provide written consent

- laboratory exam results within the normal range for healthy individuals and/or

medically acceptable defined by a clinical investigator;

- feeding habits consistent with the standardization of the study

Exclusion Criteria:

- pregnancy

- history of hypersensitivity to penicillins (normal or idiosyncratic drug reaction)

- any evidence of dysfunction or clinically significant deviation from normal

- history of any psychiatric illness that might compromise the ability to provide

written consent

- history of gastrointestinal disease, hepatic, renal, pulmonary, cardiovascular,

hematological, neurological or diabetes or glaucoma

- active smoker

- consumption of more than 5 cups of coffee or tea per day

- history of drug dependence or abuse of alcohol consumption

- use of enzymatic-inducers drugs within 30 days or any systemic medication (including

prescription drugs, such as painkillers, hepatoprotective, influenza, etc) within 14 days before the start of the study

- participation in any clinical study in 9 weeks prior to the study

- have lost or donated more than 350 mL of blood in the last three months

- have been subjected to abnormal diet for any reason (therapeutic, aesthetic,

religious, etc.)

- did not have adequate venous access.

Locations and Contacts

BIOAGRI Laboratórios Ltda, Piracicaba, SP 13412-000, Brazil
Additional Information

Related publications:

Baglie S, Rosalen PL, Franco LM, Ruenis AP, Baglie RC, Franco GC, Silva P, Groppo FC. Comparative bioavailability of 875 mg amoxicillin tablets in healthy human volunteers. Int J Clin Pharmacol Ther. 2005 Jul;43(7):350-4.

Starting date: February 2005
Last updated: August 28, 2013

Page last updated: August 23, 2015

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